Inflatable spiral traction device, system, and method

ABSTRACT

Traction devices, systems, and methods for their use provide simultaneous axial distraction and one of flexion, extension, or lateral flexion of the spine. The devices permit aligning at least a portion of the spine prior to traction. Traction is applied through air chambers configured and dimensioned to independently apply traction to the chin, and both occipital processes. Spiral traction procedures use sequential inflation of the air chambers, thereby providing axial distraction with spinal joint decompression and simultaneous paraspinal soft-tissue mobilization and/or manipulation. Automated systems and methods are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Application No. 60/664,830,filed Mar. 24, 2005 and U.S. Application No. 60/737,833, filed Nov. 16,2005, the disclosures of which are incorporated by reference in theirentireties. This application is also related to U.S. application Ser.No. ______ (Attorney Docket No. RIROGA.001A), filed concurrently withthe present application, which is incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This disclosure generally relates to treatment of the spine, and moreparticularly to devices, systems, and methods for simultaneous axialdistraction, and one of flexion, extension, or lateral flexion of thespine.

2. Description of the Related Art

A clinical study of cervical traction devices (Patrick P. Venditti, etal., J. Neuromusculoskeletal Sys. 1995, 3(2):82-91, the disclosure ofwhich is incorporated by reference) has been found to separate thearticular surfaces of the cervical vertebral joints, thereby increasingthe spinal-disc height. None of the tested devices relaxed the neckmuscles.

SUMMARY OF THE INVENTION

Traction devices, systems, and methods for their use providesimultaneous axial distraction and one of flexion, extension, or lateralflexion of the spine. The devices permit aligning at least a portion ofthe spine prior to traction. Traction is applied through air chambersconfigured and dimensioned to independently apply traction to the chin,and both occipital processes. Spiral traction procedures use sequentialinflation of the air chambers, thereby providing axial distraction withspinal joint decompression and simultaneous paraspinal soft-tissuemobilization and/or manipulation. Automated systems and methods are alsoprovided.

Accordingly, some embodiments provide a cervical traction systemcomprising a C-shaped inflatable, four-chamber cervical collarcomprising: a front and a back, a right end and a left end defining aback opening; a bottom section comprising an inflatable bottom chamberin fluid connection with a first tubing port; a top section disposed onthe bottom section; and a releasable closure for closing the backopening between the right end and the left end. The top sectioncomprises: an inflatable right rear chamber in fluid connection with asecond tubing port, wherein the right rear chamber is disposed towards aright end of the top section, an inflatable left rear chamber in fluidconnection with a third tubing port, wherein the left rear chamber isdisposed towards a left end of the top section, and an inflatable frontchamber in fluid connection with a fourth tubing port. The front chamberis disposed between the right rear chamber and the left rear chamber,and a chin cup disposed at a front end of the front chamber.

In some embodiments, the releasable closure comprises a plurality ofstraps and corresponding pegs. Each peg comprises a shank and anenlarged head. Each strap comprises: a first end and a second end; aplurality of openings extending from the first end toward the secondend, wherein each opening comprises a larger portion proximal to thesecond end and a smaller portion proximal to the first end; the largerportion is sized and dimensioned to pass over the enlarged head of thepeg; and the smaller portion is sized and dimensioned to accept theshank, but not to pass over the enlarged head of the peg. The second endof the strap is secured to one of the right end or left end of thecollar, extending toward the opening, and the corresponding peg issecured to the other of the right end or left end of the collar.

Some embodiments further comprise a first front strap securing the frontchamber to the right rear chamber; and a second front strap securing thefront chamber to the left rear chamber.

In some embodiments, the chin cup is permanently coupled to the frontchamber. In some embodiments, the chin cup is generallyboomerang-shaped, comprising a pair of arms converging at a point; thepoint is disposed at the front of the collar; and the chin cup is sizedand dimensioned such that the point is positioned under a user's chinand the arms extend about halfway to the angle of the mandible.

Some embodiments further comprise a right and a left temporomandibularjoint spacer, each temporomandibular joint spacer comprising an innerwall, an upper wall, and an outer wall defining a channel, wherein thechannel is sized and configured to cover at least partially the bitingsurface of at least one of the user's molars or premolars.

Some embodiments further comprise a gas manifold in fluid connectionwith the tubing ports of the bottom chamber, the right rear chamber, theleft rear chamber, and the front chamber; and a source of pressurizedgas for influx into the gas manifold.

Also provided is a method for simultaneous axial distraction, and atleast one of flexion, extension, and lateral flexion of a user's neckcomprising: securing the cervical collar of claim 1 to the neck of apatient; inflating the bottom chamber to contact the chin cup with theuser's chin; inflating the right and left rear chambers to contact rightand left occipital regions of the user's head; applying cervicaltraction by sequential inflation of at least two of the top sectionchambers; deflating at least one of the top section chambers; andoptionally repeating applying cervical traction.

In some embodiments, the sequential inflation comprises at least one ofthe following inflation sequences: a first sequence comprising leftrear, right rear, both rear, and front; a phase-shifted variant thereof;and the reverse of the first sequence or phase-shifted variant.

In some embodiments, the sequential inflation comprises at least one ofthe following inflation sequences: a second sequence comprising leftrear, both rear, right rear, front; a phase-shifted variant thereof; orthe reverse of the second sequence or phase-shifted variant.

Also provided is a neck-and-upper-back frame system for cervicaltraction on a user comprising: a top and a bottom; a front and a back; aleft side and a right side; a neck frame; and a shoulder framecomprising right and left shoulder pads sized and dimensioned forsimultaneously engaging a user's right and left shoulders, respectively,wherein each shoulder pad comprises a front end and a back end defininga longitudinal axis, and the neck frame is coupled to the shoulderframe, and the neck frame's position with respect to the shoulder frameis adjustable. The neck frame comprises: a plurality of lockablyslidable slats; an inflatable front chamber sized and dimensioned toengage a user's chin, and coupled to at least one of one of the slats;an inflatable right rear chamber sized and dimensioned to engage theright occipital region the user's head, and coupled to at least one ofthe slats; and an inflatable left rear chamber sized and dimensioned toengage the left occipital region the user's head, and coupled to atleast one of the slats, wherein the plurality of slats is slidablyadjustable for simultaneous engagement of the front chamber to theuser's chin, the right rear chamber to the right occipital region of theuser's head, and the left rear chamber to the left occipital region ofthe user's head.

In some embodiments, the neck frame is swivelably coupled to theshoulder frame. In some embodiments, each shoulder pad comprises aninflatable shoulder chamber positioned to contact the user's shoulder.

Some embodiments further comprise an upper-back frame operativelycoupled to the back ends of the shoulder pads, wherein the upper-backframe comprises: an inflatable right upper-back chamber sized anddimensioned to contact a user's right upper back; and an inflatable leftupper-back chamber sized and dimensioned to contact a user's left upperback, wherein the upper-back frame and shoulder frame together aresecurable to the user.

In some embodiments, the sliding of at least one of the slats islockable using a slat sleeve comprising a plunger sized and dimensionedto engage an opening in the slat-to-be-locked.

In some embodiments, the plurality of slats comprises: a left lateralslat and a right lateral slat generally defining right and left sides ofa rectangle; and a rear slat and a front slat generally defining rearand front sides of the rectangle; a right occipital cup comprising theright rear chamber is coupled to the rear slat; a left occipital cupcomprising the left rear chamber is coupled to the rear slat; and a chincup comprising the front chamber is coupled to the front slat. Someembodiments further comprise: a right slat sleeve coupled to the rightshoulder pad; and a left slat sleeve coupled to the left shoulder pad,wherein the right lateral slat is slidably coupled in the right slatsleeve; the left lateral slat is slidably coupled in the left slatsleeve; and the sliding of the lateral slat in at least one of the leftslat sleeve or the right slat sleeve is lockable.

In some embodiments, a height of at least one of the right occipitalcup, the left occipital cup, or the chin cup is user adjustable. In someembodiments, a sagittal tilt of at least one of the right occipital cup,the left occipital cup, or the chin cup is adjustable.

In some embodiments, the neck frame is lockably slidable forward andbackward relative to the shoulder frame. In some embodiments, the neckframe is coupled to a right tilting lever and a left tilting lever, theright tilting lever is lockably slidable along the longitudinal axis ofthe right shoulder pad, and the left tilting lever is lockably slidablealong the longitudinal axis of the left shoulder pad.

In some embodiments, the neck frame is lockably pivotable relative tothe shoulder frame around a transverse axis. In some embodiments, theneck frame is coupled to a right slat sleeve and a left slat sleeve; theright slat sleeve is coupled to the right shoulder pad and is lockablypivotable around the transverse axis; and the left slat sleeve iscoupled to the left shoulder pad and is lockably pivotable around thetransverse axis.

In some embodiments, the front chamber is generally boomerang-shaped,comprising a pair of arms converging at a point; the point is disposedat the front of the chin cup; and the front chamber is sized anddimensioned such that the point is positioned under a user's chin andthe arms extend about halfway to the angle of the mandible.

Some embodiments further comprise a right and a left temporomandibularjoint spacer, each temporomandibular joint spacer comprising an innerwall, an upper wall, and an outer wall defining a channel, wherein thechannel is sized and configured to cover at least partially the bitingsurface of at least one of the user's molars or premolars.

Some embodiments further comprise a gas manifold in fluid connectionwith the front chamber, the right rear chamber, and the left rearchamber; and a source of pressurized gas for influx of gas into themanifold.

Also provided is a neck-and-upper-back frame system comprising: a meansfor simultaneous axial distraction, and one of flexion, extension, orlateral flexion of a user's spine; and a means for aligning a user'supper back, wherein the distraction means is swivelably coupled to thealignment means.

Also provided is a method for simultaneous axial distraction, and one offlexion, extension, or lateral flexion of a user's spine comprising:securing a disclosed neck-and-upper-back frame system to a patient;slidably adjusting the plurality of slats to simultaneously engage thefront chamber to the user's chin, the right rear chamber to the rightoccipital region of the user's head, and the left rear chamber to theleft occipital region of the user's head; applying cervical traction bysequential inflation of the front chamber, right rear chamber, left rearchamber, or a combination thereof; deflating the front chamber, rightrear chamber, and left rear chamber; and optionally repeating applyingcervical traction.

In some embodiments, the sequential inflation comprises at least one ofthe following inflation sequences: a second sequence comprising leftrear, both rear, right rear, front; a phase-shifted variant thereof; orthe reverse of the second sequence or phase-shifted variant. In someembodiments, the sequential inflation comprises at least one of thefollowing inflation sequences: a second sequence comprising left rear,both rear, right rear, front; a phase-shifted variant thereof; or thereverse of the second sequence or phase-shifted variant.

Some embodiments further comprise at least one of extending, rotating,or laterally flexing the thoracic spine prior to applying cervicaltraction by inflating at least one of a right upper back chamber or aleft upper back chamber. Some embodiments further comprise stretchingthe user's trapezius muscles prior to applying cervical traction byinflating a right shoulder chamber and a left shoulder chamber. In someembodiments, the inflation of the front chamber, right rear chamber, andleft rear chamber is automated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates in perspective an embodiment of an inflatablefour-chamber collar. FIG. 1B illustrates a perspective view of anembodiment of a chin cup. FIGS. 1C and 1D illustrate embodiments of aclosure comprising a peg in side view and a strap in top view,respectively.

FIG. 2 illustrates in perspective view an embodiment of a manuallyoperated manifold and gas bulb.

FIG. 3 illustrates in perspective view an embodiment of atemporomandibular joint (TMJ) spacer.

FIG. 4 is a flowchart illustrating a method for using the inflatablefour-chamber collar of FIG. 1.

FIG. 5A is a perspective view illustrating schematically a configurationof an embodiment of a traction system comprising the collar of FIG. 1,the manifold of FIG. 2, and the TMJ spacer of FIG. 3. FIG. 5Bschematically illustrates a top view of the collar of FIG. 1. FIGS. 5Cand 5D are side views of the skull and TMJ spacer of FIG. 3 illustratingthe unloading of the TMJ during the spiral traction procedure.

FIGS. 6A, 6B, and 6C are side, back and front views, respectively, of anembodiment of a neck-and-upper-back frame. FIG. 6D is a schematic topview of an embodiment of a neck frame.

FIGS. 6E and 6F are top and side views, respectively, of an embodimentof a lateral slat.

FIG. 6G is a perspective view of an embodiment of a front chamber.

FIGS. 6H, 6I, and 6J are a side view in the locked position, a side viewof in the unlocked position, and a rear view in the locked position,respectively, of an embodiment of a rear slat sleeve.

FIGS. 6K and 6L are a side view and a rear view in the locked position,respectively, of an embodiment of a front slat sleeve. FIG. 6M is a sideview of another embodiment of a front slat sleeve.

FIG. 6N is a front view of an embodiment of a lateral slat sleeve.

FIGS. 6O, 6P, and 6Q are side views of three embodiments of a rearbracket.

FIGS. 7A and 7B are side and front views, respectively, of an embodimentof a neck-and-upper-back frame that includes a lower cervical tilt.

FIG. 7C is a front view of an embodiment of a lateral slat sleeve.

FIGS. 8A and 8B are side and front views, respectively, of an embodimentof a neck-and-upper-back frame that includes a adjustable chin andoccipital cups.

FIGS. 8C, 8D, and 8E are side, back, and top views, respectively of anembodiment of an adjustable occipital cup.

FIGS. 8F, 8G, 8H, and 8I are top, bottom, detail, and cross sectionviews of an embodiment of a rear slat.

FIGS. 8J and 8K are side and back views respectively of an embodiment ofa chin cup.

FIGS. 8L and 8M are top and side views of an embodiment of a front slat.

FIGS. 9A and 9B are side and front views, respectively, of an embodimentof a neck-and-upper-back frame that includes a middle cervical tilt.

FIG. 9C is a front view of an embodiment of a lateral slat sleeve.

FIG. 10 illustrates in perspective view an embodiment of a manuallyoperated manifold and gas bulb.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of disclosed devices, systems, and methods exhibit at leastsome of the following features, which are discussed in greater detailbelow. Embodiments of the devices are portable, compact, lightweight,and easily assembled and disassembled. Accordingly, they are suitablefor both clinical and home use. Embodiments of devices permit the neckto be oriented in any position (rotation, flexion, extension, sideextension) prior to traction. Traction of the neck and upper back usesup to seven points of contact. The neck traction uses spiral pathways(spiral traction). Aligning the upper-thoracic spine reduces thoracickyphosis (hunched posture), internal rotation of the shoulders (roundedshoulders), and/or upper-thoracic rotational scoliosis.Temporo-mandibular joints (TMJs) are decompressed. The traction uses alow traction force.

FIG. 1A illustrates in perspective an embodiment of an inflatablefour-chamber collar 100 comprising a front 102, a back 104, a topsection 106, a bottom section 108, a right side 110, and a left side112. The collar 100 is generally C-shaped, with an opening 114 at theback 104. The opening 114 is defined by a first or right end 116, and asecond or left end 118. The opening 114 permits a user to position thecollar 100 around the neck. As will become apparent below, providing theopening 114 in the back provides a unitary traction force on the user'schin, rather than a divided force, which would result from afront-opening device. Moreover, it is difficult to equalize the dividedforce in some embodiments of a front opening device, resulting in an offcenter force. Some embodiments of the collar 100 are supplied in a rangeof sizes, for example, to accommodate different neck sizes in adults andchildren.

The illustrated collar 100 comprises four air chambers, each of which isindependently inflatable and deflatable. In some embodiments, eachchamber comprises sub-chambers in fluid connection. The bottom section108 comprises a bottom chamber 140 extending from the first end 116 tothe second end 118. The bottom chamber 140 serves as a platform for atop section 106, which comprises three upper air chambers: a frontchamber 150 is disposed in the front 102 of the collar, and a right rearchamber 160 and left rear chamber 170 flanking the front chamber 150. Insome embodiments, the length of the front chamber 150 is from about ⅓ toabout ½ of the total length of the upper section 106. {check figures} Inthe illustrated embodiment, the front chamber 150 does not contacteither the right 160 or left 170 rear chamber, and is independentlysecured to each using front straps 180. In the illustrated embodiment,the front straps 180 are secured using rivets 182. Those skilled in theart will understand that other embodiments use other fastening meansknown in the art, for example, adhesives, laces, hooks, stitching,screws, bolts, pins, hook-and-loop fasteners, combinations, and thelike. In some embodiments, at least one end of a front strap 180 issecured to an outer layer, which is discussed in greater detail below.In preferred embodiments, one or both ends of the front straps 180 haveat least some rotational freedom of motion, thereby accommodating therelative motion of the air chambers as they are inflated and/ordeflated. In other embodiments, the front chamber 150 contacts at leastone of the right 160 and/or left 170 rear chambers.

The air chambers comprise any suitable material. In general, at leastone of the materials is flexible and airtight. In some embodiments, atleast one of the materials is elastic, and expandable, for example,natural rubber, synthetic rubber, elastomeric polymers, elastomericfabrics, elastomeric fibers, combinations, and the like. Otherembodiments do not use an elastic and/or expandable material. In someembodiments, the air chambers comprise a composite, for example, afabric impregnated with and/or laminated with a polymer and/or rubber.In some preferred embodiments, the air chambers comprise a polymer, forexample, polyvinyl chloride (PVC). In some embodiments, the air chamberscomprise a single material. In other embodiments, one or more of the airchambers comprises a plurality of materials. In the illustratedembodiment, each air chamber comprises accordion-type pleating orcorrugations, which permit the air chambers to expand and contractvertically as each is inflated and deflated. In other embodiments, onlysome or none of the air chambers comprises pleating.

In some embodiments, at least a portion of an air chamber is disposed inand/or covered by one or more outer layers, which, for example,constrains the shape of the air chamber during inflation and/ordeflation, and/or protects the air chamber, for example, providingpuncture resistance. The outer layer(s) comprises one or more materialsthat provide desired properties. For example, in some embodiments,portions of the cover likely to contact a user's skin comprise a wickingmaterial. In some embodiments, the outer layer forms a bag and/or coverin which the air chambers are disposed.

The bottom chamber 140 comprises a tubing port 142 through which thebottom chamber 140 is inflated and/or deflated. The bottom chamberfurther comprises left and right cutouts 144 (only the left cutout isvisible in FIG. 1A) sized and dimensioned to engage a user's uppertrapezius (shoulder) area.

The left rear chamber 170 comprises a tubing port 172 through which theleft rear chamber 170 is inflated and/or deflated. A left occipitalsupport 174 is provided to engage the left occipital region of the head.In the illustrated embodiment, the left occipital support 174 is acutout in the left rear chamber 170 sized and dimensioned to engage theleft occipital region of the head.

The right rear chamber 160 comprises a tubing port 162 (not visible inFIG. 1A) through which the right rear chamber 160 is inflated and/ordeflated. A right occipital support 164 is provided to engage the rightoccipital region of the head. In the illustrated embodiment, the rightoccipital support 164 is a cutout in the right rear chamber 170 sizedand dimensioned to engage the right occipital region of the head.

The front chamber 150 also comprises a tubing port (not visible in FIG.1A) through which the front chamber 150 is inflated and/or deflated. Acutout 154 is formed in the front of the front chamber 150 that is sizedand dimensioned to cradle and support a user's chin. A chin cup 190 (notvisible in FIG. 1A) is secured in the cutout 154. A preferred embodimentof the chin cup 190 is best viewed in FIG. 1B. The illustrated chin cup190 is generally boomerang-shaped with a point 192 formed at theintersection of a pair of arms 194. The chin cup 190 comprises aflexible outer shell, which preferably comprises a polymer. Corrugationsor pleats 196 are provided on the sides of the chin cup 190, whichaccommodate height changes as the chin cup 190 is compressed andreleased. In some embodiments, a compressible fill material and/or fluidfill material is provided in the interior of the chin cup 190. In theillustrated embodiment, the chin cup 190 is substantially permanentlysecured to the cutout 154. In other embodiments, the chin cup 190 isremovably secured, for example, to change the size of the chin cup.Undesirable movement of the chin cup 190 occurs in some embodiments inwhich the chin cup 190 is removable. Accordingly, in some preferredembodiments, the chin cup 190 is permanently secured.

The point 192 generally points forward in the cutout 154, and supportsthe chin. The arms 194 are positioned below the mandible. In theillustrated embodiment, each arm 194 extends from the front of a user'schin to about half the distance to the angle of the mandible.Accordingly, a range of sizes of chin cups 190 accommodate different jawsizes in some embodiments. The thickness of the illustrated chin cup 190is from about 1 cm (about 0.4″) to about 4 cm (about 1.6″), preferablyfrom about 2 cm (about 0.8″) to about 3 cm (about 1.2″). Those skilledin the art will understand that other dimensions and/or shapes areuseful in other embodiments. In other embodiments, chin cup 190integrally formed in the cutout 154.

The collar 100 is fastened around the neck of a user using fasteningand/or closure means 120 known in the art, for example, using straps,buttons, laces, D-rings, slide fasteners (zippers), hook-and-loopfasteners (Velcro®), buckles, clasps, hooks, combinations, and the like.In some embodiments, at least one of the fasteners is secured to one ormore of the air chambers. In some embodiments, at least one of thefasteners is secured to an outer layer described above. In someembodiments, the fasteners are not secured to the collar 100, forexample, straps encircling the collar 100. In some preferredembodiments, the fastening means 120 are adjustable, thereby permittingthe user to adjust the fit of the collar 110. The embodiment illustratedin FIG. 1A includes a preferred fastening means 120 comprising aplurality of straps 122 secured proximal to the left end 118 of thecollar, and corresponding pegs, rivets, and/or buttons 130, which arenot illustrated in FIG. 1A, secured proximal to the right end 116 of thecollar. In the illustrated embodiment, two each of the straps 122 andpegs 130 are secured to the bottom chamber 140, and one strap 122 andpeg 130 are secured to the left 170 and right 160 rear chambers,respectively. Those skilled in the art will understand that, in otherembodiments, the positions of one or more of the straps 122 and pegs 130are reversed, for example, to provide left and right-handed models ofthe collar 100. Other embodiments use a different number and/orconfiguration of straps and pegs.

FIG. 1C is a side view of a peg, rivet, or button 130 comprising a shank132 secured proximal to the right end 116 of the collar and an enlargedhead 134. In some embodiments, the peg 130 is substantiallycylindrically symmetric, while in other embodiments, the peg 130 is notcylindrically symmetric. The shank 132 of the peg is secured to theright end 116 collar using any means known in the art, for example,using a rivet, screw, bolt, pin, stitching, adhesive, combinations, andthe like. The peg 130 comprises any suitable material, for example, ametal, ceramic, inorganic materials, biological materials, and/orpolymer. Composites, some of which are fiber reinforced, are alsosuitable.

FIG. 1D is a top view of a strap 122, which comprises first end 124proximal to the left end 118 of the collar, and a second end 125, whichextends toward the right end 116 of the collar in the illustratedembodiment. The strap 122 is secured to the left end 118 using afastener 126 of any suitable type known in the art, for example, arivet, screw, bolt, pin, stitching, adhesive, combinations, and thelike. In preferred embodiments, the fastener 126 permits the strap 122at least a degree of rotational freedom, which permits some relativemotion during inflation and/or deflation of the air chambers. Theillustrated embodiment further comprises a plurality of openings 128,each of which has a larger portion 128 a proximal to the first end 124,and a smaller portion 128 b proximal to the second end 125. The largerportion 128 a is dimensioned and sized to pass over the enlarged head134 of the peg. The smaller portion 128 b is dimensioned and sized toaccommodate the shank 132 of the peg, but not to pass over the enlargedhead 134. The plurality of openings 128 provides a range of sizes forthe collar 100. In some embodiments, at least a portion of the opening128 is reinforced, for example, using a grommet, by stitching, and/orusing other means known in the art. The strap 122 comprises any suitablematerial, for example, leather, fabric, polymer, combinations, and thelike. In some embodiments, the material is a composite, which is fiberand/or fabric reinforced in some embodiments.

In use, the collar 100 is positioned around a user's neck with theopening 114 facing backwards. The user selects an opening 128 on eachstrap that provides the desired fit, and passes the larger portion 128 aof the opening over the enlarged head 134 of the corresponding button130. In the illustrated embodiment, the straps 122 and pegs 130cooperatively secure the collar 100 to the user with reduced rates ofslipping and/or failure. Inflating the air chambers in the collar 100causes expansion of both the height and diameter of the collar 100.Increasing the diameter applies tension to the straps 122, therebycausing the shank 132 to lodge in the smaller portion 128 b of theopening. Because the head 134 of the button is larger than the smallerportion 128 b of the opening, the closure resists slipping.

As discussed above, the fastener(s) 120 provide a degree ofadjustability in the diameter of the collar 120. In some preferredembodiments, the collar 100 is provided in a plurality of diameters, forexample, small, medium, and large for adults to accommodate a range ofneck sizes. Some embodiments of the collar 100 are also sized forchildren. In the illustrated embodiment, the bottom section 108 is fromabout ⅓ to about ⅔ of the total height of the collar 100, morepreferably, about ½ of the total height of the collar 100 in theuninflated state. On inflation, the height of the collar 100 increasesto a maximum of from about 125% to about 500% of the uninflated height,preferably, from about 200% to about 300%. In some embodiments, thewidths of different portions of the collar 100 are different, forexample, wider under the chin cup 190 and/or at the cut outs, 164 and174. The maximum inflated width of the collar 100 is from about 125% toabout 200% of the uninflated width. Those skilled in the art willunderstand that the inflation characteristics of each are chamber areindividually selectable according the particular application. Forexample, in some embodiments, the different air chambers have differentmaximum inflation sizes as a percentage of the uninflated size.Moreover, those skilled in the art will understand that some embodimentsof the air chambers inflate anisotropically, for example, the change inheight is different from the change in width as a percentage of theuninflated size.

Tubing ports are each fluidly connected to one or more sources of apressurized gas. In preferred embodiments, each of the tubing ports 142,152, 162, and 172 is fluidly connected to a manifold, which in preferredembodiments, permits the use of a single source of pressurized gas. Themanifold fluidly connects the tubing ports 142, 152, 162, and/or 172 toa source of pressurized gas or to the ambient atmosphere, therebypermitting the independent inflation and deflation of the correspondingair chambers 140, 150, 160, and 170, respectively. Suitable manifoldsare known in the art. In some embodiments, the manifold is manuallycontrolled. In preferred embodiments, the manifold is under automaticcontrol, for example, using a computer, microprocessor, or the like. Insome embodiments, the source of pressurized gas is user generated, forexample, a hand bulb, foot pump, user operated pump, or the like. Inpreferred embodiments, the source of pressurized gas is not usergenerated, for example, a mechanical pump or a compressed gas cylinder.In some embodiments, the speed of inflation and/or deflation of each airchamber is independently controllable. In some embodiments, at leasttwo, and preferably all, of the tubing ports 142, 152, 162, and 172 aredisposed on a single connector that permits a simple, one stepconnection of all of the tubing ports 142, 152, 162, and 172 to themanifold. In some embodiments, the connector is designed to preventimproper connection. In some embodiments, the connector is a quickrelease connector.

FIG. 2 illustrates an embodiment of an embodiment of a user operatedmanifold or air shunting valve 200 comprising a plurality of tubingports, each of which corresponds to an air chamber of the collar 100.Port 240 is fluidly connected to the tubing port 142 of the bottomchamber. Port 250 is fluidly connected to the tubing port 152 of thefront chamber. Port 260 is fluidly connected to the tubing port 162 ofthe right rear chamber. Port 270 is fluidly connected to the tubing port172 of the left rear chamber. Connections are made using tubing, forexample, rubber, PVC, or other tubing known in the art. In theillustrated embodiment, pressurized gas is provided using a hand bulb210. The manifold 200 comprises valves that selectively andindependently fluidly connect each port or a combination thereof witheither the hand bulb 210, or with ambient pressure. The valve labeled“1” controls port 270, and consequently, the inflation and deflation ofthe left rear chamber 170. The valve labeled “2” controls port 260, andconsequently, the inflation and deflation of the right rear chamber 160.The valve labeled “3” controls ports 260 and 270, and consequently, theinflation and deflation of both the right 160 and left 170 rearchambers. The valve labeled “4” controls port 250, and consequently, theinflation and deflation of the front chamber 150. The valve labeled“Bottom” controls port 240, and consequently, the inflation anddeflation of the bottom chamber 140. Some embodiments also comprise oneor more quick release valves that release the pressure from one or moreof the air chambers (not illustrated), for example, in a slow andcontrolled manner. The quick release valve in some preferred embodimentsrelease the pressure from the top section 106 (front, left rear, andright rear) air chambers. Some embodiments comprise a quick releasevalve that releases the pressure from all four air chambers.

FIG. 3 illustrates an embodiment of a right temporo-mandibular joint(TMJ) or dental 300. The illustrated embodiment of the TMJ spacercomprises a body 310 and a flexible cord or leash 320. The body 310comprises a channel 312 sized and dimensioned to cover the bitingsurfaces of the user's molars, and optionally, the premolars,collectively 330. In the illustrate embodiment, the covered teeth are ofthe lower jaw. Those skilled in the art will understand that in someembodiments, the channel 312 covers the teeth of the upper jaw, and/orboth jaws. The channel 312 defines an inner wall 314, an upper wall 316,and an outer wall 318. In some embodiments, the thicknesses of the walls314, 316, and 318 are independently from about 1 mm (0.04″) to about 4mm (0.16″), preferably, about 1.5 mm±0.7 mm ( 1/16″± 1/32″). In somepreferred embodiments, the walls 314, 316, and 318 have substantiallythe same thicknesses. The body 310 comprises any suitable material, forexample, a polymer. Examples of suitable polymers include polyethylene,polypropylene, and the like. In preferred embodiments, the body 310 ismanufactured as a single piece from a single material, thereby reducingmanufacturing costs. The cord 320 is secured to the outer wall 318, andprevents swallowing of the TMJ spacer 300. A left TMJ spacer (notillustrated) is also typically used, which is substantially identical tothe right TMJ spacer 300, but is disposed on the other side of theuser's jaw. In some preferred embodiments, the cords 320 of the left andright TMJ spacers 300 are joined. The TMJ spacers protect the user'steeth and TMJ, as discussed below.

FIG. 4 is a flowchart illustrating an embodiment of a method 400 forusing the collar 100 with reference to FIGS. 1A-1D, 2, 3, 5A, and 5B. Instep 410, traction device is positioned on the user. The collar 100 ofFIG. 1 is positioned and fastened around a user's neck, as illustratedin FIG. 5A. As discussed above, the collar 100 is fastened with theopening towards the user's back using the provided fastening means. Theshoulders are engaged in cutouts 144 provided on the bottom chamber. Themanifold 200 and hand bulb of FIG. 2 is connected to the tubing ports ofthe collar 100 with tubing, as discussed above. Right and left TMJspacers 300 (only right illustrated) are positioned over the user'smolars and are held in place between the upper and lower jaws. In theembodiment illustrated in FIG. 5A, the user's torso is upright, forexample, sitting or standing. Any body position is useful in practicingmethod 400, however. For example, in other embodiments, the user islying down, reclining, or in another position.

In step 420, the spine is oriented or aligned using the device 100. Thebottom chamber 140 is inflated until the chin cup 190 contacts theuser's chin (acupuncture: gall bladder 20). The rear chambers 160 and170 are inflated until the occipital cutouts 164 and 174 of the rightand left rear chamber contact the user's occipital regions of the head(acupuncture: conception vessel 23). Inflating the bottom chamber alsoapplies downward pressure on tops of the user's shoulders (uppertrapezius muscles; acupuncture: gall bladder 21). The cervical vertebraeare aligned in flexion, extension, and lateral flexion in this step.

In step 430, traction is applied to the spine. The design of the collarpermits simultaneous axial distraction, and one of selective flexion,extension or lateral flexion of the neck using the three air chambers inthe top section 106 of the collar. FIG. 5B is a schematic top view ofthe top section 106 of the collar: the front connector 150, right rear160, and left rear 170 chambers. Inflating the left rear chamber tiltsthe neck to the right. Inflating the right rear chamber tilts the neckto the left. Inflating both the left and right rear chambers tilts theneck forward (flexion). Inflating the front chamber tilts the neck back(extension).

Preferred sequences for inflating the air chambers are referred toherein as “spiral traction.” As used herein, the term “spiral traction”refers to both sequences comprising steps of cervical tractioncontemporaneous with neck extension, flexion, or lateral flexion, aswell as treatment methods comprising such sequences. The particular usewill be clear based on the context. One preferred sequence is referredto as a “figure-eight sequence,” and uses the following inflationsequence: left rear, right rear, both rear, front. Another preferredsequence is referred to herein as a “circular sequence,” and uses thefollowing inflation sequence: left rear, both rear, right rear, front.Those skilled in the art will understand that some embodiments of thespiral traction sequences have different start and end points, forexample, starting with the front chamber, that is the sequence is phaseshifted. Those skilled in the art will also understand that the order ofthe steps in the sequence is reversed in some embodiments, for example,right rear before left rear.

In some preferred embodiments, the inflation rates for the air chambersare controlled to provide a desired therapeutic effect. For example,embodiments of the method provide one or more of spinal traction,mobilization, and/or manipulation. Mobilization typically refers tolow-speed methods, while manipulation refers to high-speed methods.Accordingly, embodiments of the disclosed method 400 providesimultaneous spinal mobilization and axial distraction. Embodimentsusing an automated manifold and a non-user generated source ofpressurized gas are particularly useful for controlling inflation rates.Some preferred embodiments use a low traction force, which is possiblebecause of muscles are relaxed during the traction.

The TMJ spacers 300 unload the temporo-mandibular joint (TMJ) during thespiral traction procedure. FIG. 5C is a side view of the skullillustrating the occipital bone 510, temporal bone 520, and mandible530. The temporo-mandibular joint (TMJ) 540 is formed between thecondylar process 550 of the mandible and the temporal bone 520. Theinternal and external lateral ligaments 570 and stylo-mandibularligaments 580 stabilize the TMJ. Also illustrated are the TMJ spacer 300and the chin cup 190. Inflating one or both of the rear chambers 160and/or 170 applies a force F to the occipital bone 510, which istransferred through the skull to the chin cup 190. The TMJ spacer 300acts as the fulcrum of a first-class lever between the TMJ 540 and thechin cup 190, thereby unloading the TMJ 540. FIG. 5D illustrates thesituation when the front chamber 150 is inflated, thereby applying aforce F directly to the chin cup 190 and unloading the TMJ as discussedabove. Embodiments of the TMJ spacer also separate the mandible 530 fromthe maxilla 590, thereby reducing or eliminating pressure on the frontteeth.

It is believed that reactive spasms of the masseter and posteriorcervical musculature is avoided by three mechanisms. The lever action ofthe TMJ spacers 300 unload both TMJs during forward, backward, and sidetilting of the neck. Lifting the temporal bones away from the jaw by therear chambers 160 and 170 unloads both TMJs during forward and backwardtilting of the neck, and unloads the ipsilateral TMJ during sidetilting. Cushioning by the chin cup and front chamber unloads thecontralateral TMJ during side tilting.

Those skilled in the art will understand that the collar 100 is alsouseful for traditional, axial neck traction by inflating the front andboth rear chambers simultaneously.

In step 440, the air chambers are deflated slowly. In some embodiments,the top section 106 (front 150 and rear 160 and 170) chambers aredeflated, but the bottom chamber 140 is not, thereby not affecting thealignment provided by the bottom chamber 140. In some embodiments, allof the air chambers are deflated.

In step 450, steps 430 and 440 are optionally repeated. If the bottomchamber 140 was deflated in step 440, step 420 is also repeated.Preferably, the steps are repeated from about 1 to about 9 times, morepreferably, about 2 to about 4 times. In some embodiments, one or moredifferent spiral traction sequences are used in the repeated step 440.

FIGS. 6A-6C are a side view, a back view, and a front view,respectively, of an embodiment of a neck-and-upper-back frame 6000useful for applying traction to the neck and upper spine. As best seenin FIG. 6B, the device 6000 comprises a neck frame 6000 a, a shoulderframe 6000 b, and an upper-back frame 6000 c. Portions of the neck frame6000 a are not illustrated in the front view 6C.

As best viewed in FIGS. 6A and 6B, the illustrated embodiment of theneck frame 6000 a comprises a pair of lateral slats 6010, a rear slat6020, and a front slat 6030 (not illustrated in FIG. 6B). One lateralslat 6010 is disposed on either side of the user's head. The rear slat6020 is slidably secured to both lateral slats 6010, and is disposedbehind the user's head. The front slat 6030 is slidably secured to thelateral slats 6010, and is disposed in front of the user's neck, belowthe chin. In a schematic top view illustrated in FIG. 6D, collectively,the right lateral slat 6010 a, left lateral slat 6010 b, rear slat 6020,and front slat 6030 form a rectangle. Each lateral slat 6010 comprises afirst or front end 6012 and a second or back end 6014. The front end6012 of each lateral slat is positioned in front of the user's head, andthe back end 6014 is positioned behind the user's head. The rear slat6020 comprises a first or right end 6022 and a second or left end 6024.The front slat 6030 also comprises a first or right end 6032 and asecond or left end 6034. The right ends of the rear 6022 and front 6032slats are positioned to the right of the user's head, while the leftends of the rear 6024 and front 6034 slats are positioned to the left ofthe user's head.

As used herein, the term “slat” refers to elongate substantially rigidstructures of any suitable cross-section, and includes structures suchas slats, rods, beams, tubes, rails and other structures known in theart. In some embodiments, the slats have a substantially constant crosssection along the length. In other embodiment, the cross section of theslat is not constant. Slats comprise any suitable material known in theart, for example, wood, wood composites, metals, polymers, inorganicmaterials, and combinations thereof. In some embodiments, the slatscomprise a composite, for example, a fiberglass composite, a woodcomposite, and/or a carbon fiber composite.

Returning to FIG. 6A, the rear slat 6020 is mounted to the lateral slats6010 using a pair of rear slat sleeves 6100. In the illustratedembodiment, each rear slat sleeve 6100 is substantially immovablysecured to a corresponding lateral slat 6010. Each rear slat sleeve 6100permits relative lockably slidable left-right motion between the rearslat 6020 and the corresponding lateral slat 6010. In the illustratedembodiment, the rear slat sleeves 6100 maintain a substantiallyperpendicular relationship between the rear slat 6020 and each lateralslat 6010. Details of the construction of the rear slat sleeves 6100 areprovided below.

The front slat 6030 is mounted to the lateral slats 6010 using a pair ofrear slat sleeves 6200. In the illustrated embodiment, each front slatsleeve 6200 is lockably slidably mounted to a corresponding lateral slat6010, thereby permitting front-back motion of the front slat sleeve 6200along the corresponding lateral slat 6010. Each front slat sleeve 6200permits relative lockably slidable left-right motion between the frontslat 6030 and the corresponding lateral slat 6010. In the illustratedembodiment, the front slat sleeves 6200 maintain a substantiallyperpendicular relationship between the front slat 6030 and each lateralslat 6010. Details of the construction of the front slat sleeves 6200are provided below.

FIGS. 6E and 6F illustrate top and side views respectively of anembodiment of the lateral slats 6010. Each lateral slat comprises afirst or front end 6012 and a second or back end 6014. Secured towardsthe back end 6014 is a rear slat sleeve 6100. As illustrated in FIG. 6E,the rear slat 6020 is substantially perpendicular to the lateral slat6010 in the rear slat sleeve 6100. A series of openings or holes 6016extend from the first end 6012 towards the second end 6014. Theseopenings 6016 comprise a component in the locking mechanism of anembodiment of the front slat sleeve 6200 as described below. In theillustrated embodiment, the openings 6016 extend through the lateralslat 6010 from the top to bottom. As shown in FIG. 6F, a second seriesof longitudinally extending holes or openings 6018 are provided on thesides of the lateral slat 6010. The openings 6018 comprise a componentin an embodiment of a mechanism for locking the lateral slat 6010 in thelateral slat sleeve 6100. The openings 6018 are also useful in anembodiment of a front slat sleeve illustrated in FIG. 6M and describedbelow. Some embodiments of the lateral slats 6010 below do not compriseopenings 6016 and/or 6018, as discussed.

In the embodiment illustrated in FIGS. 6A and 6B, the rear slat 6020 andfront slat 6030 are positioned above the lateral slats 6010 as viewedfrom the side. Those skilled in the art will understand that otherarrangements are possible, for example, with both rear 6020 and front6030 to slats positioned below the lateral slats 6010, or one of therear 6020 or front 6030 slats above the lateral slats 6010, and theother below. In some embodiments, at least one of the rear 6020 or front6030 slats is substantially at the same level as the lateral slats 6010,that is, not above or below the lateral slats 6010. Those skilled in theart will understand that other arrangements are possible. As on theillustrated embodiment, a rear slat sleeve 6100 is not adjustablerelative to the lateral slat 6010. Those skilled in the art willunderstand that in other embodiments, the rear slat sleeve 6100 isadjustable relative to the lateral slat 6010, for example, forward andbackward. Those skilled in the art will also understand that, in someembodiments, the front slat sleeve 6200 is not adjustable forward andbackward relative to the lateral slat 6010.

The illustrated embodiment of the neck frame 6000 a also comprises aright occipital cup 6600 a and a left occipital cup 6600 b (generally,6600). The right occipital cup 6600 a is sized and dimensioned to engagethe user's right left occipital region of the head. Similarly, the leftoccipital cup 6600 b is sized and dimensioned to engage the user's leftoccipital region of the head.

The occipital cups 6600 are removably mounted to the top of the rearslat 6010 and are spaced to engage a user's occipital regions of thehead. The occipital cup 6600 air chambers are slightly larger than theoccipital regions of the head in some embodiments. In some embodiments,at least one of the occipital cups 6600 is longitudinally adjustablealong the rear slat 6010, thereby providing an adjustable distancebetween the two occipital cups 6600.

Also provided is a chin cup 6700 sized and dimensioned to engage auser's chin. In the illustrated embodiment, the chin cup 6700 isremovably mounted to the top of and substantially at the center of thefront slat 6030. Each of the occipital cups 6600 and the chin cup 6700comprises one or more inflatable air chambers, which are configured forindependent, user controlled inflation, as discussed in greater detailbelow.

The air chambers in the occipital cups 6600 are referred to herein as“rear chambers.” The air chamber in the chin cup 6700 is referred toherein as a “front chamber.” The air chambers comprise a flexible,substantially airtight material. In some embodiments, the air chamberscomprise an elastic material. Examples of suitable materials for the airchamber are known in the art, and include polymers, natural rubber,synthetic rubber, and the like. In some embodiments, the air chambercomprises fibers and/or a fabric embedded in and/or covered with asubstantially airtight material. Each of the air chambers comprises oneor more inflation ports through which a gas is introduced and/orremoved. One or more tubes fluidly connect the inflation ports to asource of pressurized gas, preferably through a manifold, as discussedbelow.

In some embodiments, at least one of the occipital cups 6600 and/or chincup 6700 comprises a rigid and/or semi-rigid shell and/or platform towhich the respective air chamber is secured. In some embodiments, theshell and/or platform is used to secure the occipital cup 6600 and/orchin cup 6700 to the rear 6020 and/or front 6030 slat, respectively. Insome embodiments, the shell and/or platform shields and/or protects theair chamber, for example, by covering at least a portion of the airchamber. In some embodiments, a shell and/or platform is shaped todirect the force generated by the inflation of the air chambers. In someembodiments, the shell and/or platform comprised a lightweight andformable material, for example, a polymer, a metal, wood, a woodcomposite, or the like. In some embodiments, the material is areinforced composite, for example, a fiber reinforced polymer,fiberglass, or the like. In some embodiments, one or more of the airchambers is replaceable,—for example, for providing a range of size,and/or for repair. In some embodiments, one or more of the air chambersis substantially permanently mounted to the shell and/or platform.

FIG. 6G is a perspective view of an embodiment of a front air chamber orfront chamber 6710 which is mounted in the chin cup 6700. The frontchamber 6710 is generally boomerang-shaped, with a pair of arms 6712converging at an angle to form a point 6714. The sides 6716 of the airchamber comprise a plurality of corrugations 6718, which permit thefront chamber 6710 to expand and contract vertically on inflation anddeflation. A tube 6719 in fluid connection with the interior of thefront chamber 6710 permits inflation and deflation of the front chamber.In the illustrated embodiment, the front chamber 6710 extends about halfthe distance from the front of the chin to the angle of the mandible. Insome embodiments, the front chamber 6710 is provided in a variety ofsizes to fit different users, for example, small, medium, and largesizes for adults. Some embodiments provide one or more front chambers6710 in children's sizes.

As discussed above, some of the mechanisms in the device 6000, forexample, the rear slat sleeve 6100, the front slat sleeve 6200, and thelateral slat sleeve 6300 provide releasable locking of a slat therein.Those skilled in the art will understand that any suitable locking meansknown in the art is useful. For example, in some embodiments disclosedherein, an opening or a hole is provided in a slat, and a plunger or pinon a slat sleeve engages the opening in the slat. The plunger islockable using, for example, a lever. Those skilled in the art willunderstand that the opening or hole is a through hole in someembodiments, and a blind hole in some embodiments. This mechanism isused, for example, in embodiments of the rear slat sleeve 6100, frontslat sleeve 6200, and other mechanisms described herein. Those skilledin the art will understand that other locking mechanisms known in theart are used in other embodiments. For example, in some embodiments, thelocking mechanism comprises a clutch in which two adjacent pressureplates against each other are forced against each other, for example, aportion of a slat sleeve and a portion of a slat. In some embodiments,at least one of the pressure plates comprises a textured surface and/ora high friction surface. Those skilled in the art will understand thatholes or openings in the slats described herein are optional inembodiments comprising a clutch.

Some embodiments described herein use a locking device known in the artreferred to herein as a “push button,” which comprises a first componentcomprising a spring loaded button or pin biased outward, and a secondcomponent comprising at least one opening or hole sized and dimensionedto engage the pin. The mechanism is unlocked by depressing the pin clearof the second component and moving the second component relative to thefirst component. The mechanism is locked by moving an opening of thesecond component over the pin, which is biased outward, thereby engagingthe opening. In some embodiments, operation of the mechanism isfacilitated by rounding the top of the pin and/or chamfering theopening.

Other suitable locking means known in the art are also useful, forexample, screws, detents, clips, clasps, latches, pins, pawls, notches,combinations, and the like. In some embodiments, the locking mechanismis automated, for example, using a motor, a pneumatic device, apiezoelectric device, an electromechanical device, a magnetic device,combinations thereof, and other devices known in the art.

FIGS. 6H and 6I illustrate side views, and FIG. 6J illustrates a rearview of an embodiment of a rear slat sleeve 6100. As discussed above, insome embodiments, the rear slat sleeve is fixedly secured to a lateralslat 6010. The rear slat sleeves 6100 are configured to maintain thelateral slats substantially perpendicular to the rear slat 6010.Accordingly, in some embodiments, the rear slat sleeve 6100substantially inhibits rotation between the lateral slat 6010 and therear slat 6020. The illustrated embodiment of the rear slat sleeve 6100comprises a body 6110, through which is formed a channel 6112 sized anddimensioned to slidably receive the rear slat 6020. The body 6110 ismounted on a lateral slat 6010. An upper lever arm 6120 secured to alower lever arm 6130 are pivotably mounted as a single unit near an edgeof the body 6110 using a hinge 6148. A slot 6136 extends from near thesecond end 6134 towards the first end 6132 of the lower lever arm. Inthe illustrated embodiment, the slot 6136 extends through the sides ofand opens to the bottom of the lower lever arm 6130, resulting in agenerally T-shaped cross section. A pin 6140 is slidably disposed acrossthe crossbar of the T-shaped slot 6136, as best viewed in FIG. 7J. Aspring 6142 under tension extends between the pin 6142 and the secondend 6134 of the lower lever arm. Pivotably attached to the pin 6140 is aplunger 6144, which is sized and dimensioned to engage any one of aseries of openings or holes 6026 in the rear slat (FIG. 6B).

FIG. 6I illustrates the rear slat sleeve 6100 in the unlocked position.Lifting the upper lever arm 6120 also lifts the lower lever arm 6130,thereby lifting the plunger 6144 from the opening 6026 in the rear slat.As the lower lever arm 6130 is lifted, the spring 6142 pulls the pin6140 towards the second end 6134 of the lower lever arm, therebymaintaining the plunger 6144 substantially normal to the rear slat 6020and body 6110 and preventing binding. FIG. 6J is a rear view of the rearslat sleeve 6100 in the locked position. Those skilled in the art willunderstand that the upper lever arm 6120 is optional in someemobodiments.

FIGS. 6K and 6L illustrate an embodiment of a front slat sleeve 6200that is substantially similar to the rear slat sleeve 6100 illustratedin FIGS. 6H-6J and described above. In the illustrated embodiment, thefront slat sleeve 6200 comprises a body 6210 and a first channel 6212formed therethrough, which sized and dimensioned to slidably receive afront slat 6030. The body 6210 also comprises a second channel 6214sized and dimensioned to slidably receive a lateral slat 6010. Therelative orientation of the first channel 6212 and the second channel6214 constrains a perpendicular relationship between the front slat 6030and the lateral slat 6010. The configuration of the upper lever arm6220, lower lever arm 6230, spring 6242, slot 6236, pin 6240, andplunger 6244 are substantially as described above for the rear slatsleeve 6100. In the illustrated embodiment, the plunger 6244simultaneously engages an opening in the front slat 6030 and an opening6016 in the lateral slat (FIG. 6E).

FIG. 6M illustrates an embodiment of a front slat sleeve 6200, where thefront slat 6030 and lateral slat 6010 are each provided with separatelocking mechanisms, each of which is substantially similar to thelocking mechanisms described above for the rear slat sleeve 6100. Afirst locking mechanism 6202 engages an opening in the front slat 6030.A second locking mechanism 6204 engages an opening 6018 in the lateralslat 6010 (FIG. 6F).

Returning to FIGS. 6A-6C, the shoulder frame 6000 b comprises a pair oflateral slat sleeves 6300 mounted to corresponding shoulder pads 6400.The lateral slats 6010 are mounted to the lateral slat sleeves 6300,thereby operatively joining the neck frame 6000 a to the shoulder frame6000 b. Each shoulder pad 6400 comprises a body 6410 comprising arelatively rigid, strong, and lightweight material, known in the art forexample, wood composites, polymer composite, fiberglass, metal, or thelike. In the illustrated embodiment, the body 6410 is sized anddimensioned to conform to a shoulder. The body comprises a front end6412 and a back end 6414. To the underside of the body 6410 is securedan inflatable shoulder chamber 6420. The shoulder chamber 6420 has anarched shape sized and dimensioned to conform to a user's shoulder, andin the illustrated embodiment, extends from the sternum to the acromionprocess of the scapula, and from the second or third anteriorintercostal space to the top of the scapula. Suitable materials for theshoulder chamber 6420 are discussed above and below.

To the back end 6414 each shoulder pad is mounted a rear bracket 6430extending backwards. Details of the rear bracket are provided in greaterdetail below. A shoulder strap 6450 mounted to the front end 6412 of theshoulder pad, for example, to an eyelet. A chest strap 6460 extendsacross a user's chest between the shoulder straps 6450. In theillustrated embodiment, the chest strap 6460 comprises an adjustableclasp or buckle 6462. In the illustrated embodiment, the chest strap6460 further comprises a clip 6464 for mounting the control manifold,which is discussed in greater detail below.

FIG. 6N illustrates a front view of an embodiment of a lateral slatsleeve 6300. In the illustrated embodiment, the lateral slat sleeve 6300comprises a body 1110, through which a channel 6312 is formed. Thechannel 6312 is sized and dimensioned to slidably receive a lateral slat6010 therethrough. A lever-and-plunger-type locking mechanism 6302 ofthe type described above is provided on the body 6310. The lockingmechanism 6302 releasably engages an opening 6018 in the lateral slat(FIG. 6F), thereby controlling the sliding of the lateral slat 6010 inthe channel 6312. A bushing 6316 is formed on the lower portion of thebody 1110. The bushing 6316 is sized and dimensioned to accept androtate on an enlarged head 6352 of a tilting lever 6350. In theillustrated embodiment, the head 6352 is substantially cylindrical. Thehead 6352 is formed on tilting lever 6350, which also comprises a tape6354 and a shank 6356 extending between the tape 6354 and head 6352. Theshank 6356 has a smaller diameter than the head 6352. Also provided area one or more retaining pins 6358 which retain the bushing 6316 on thehead 6352 of the tilting lever. In some embodiments, the retaining pinor pins 6358 are removable to permit disassembly. In the illustratedembodiment, the base 6354 of the tilting lever is substantially fixedlysecured to the top of the shoulder pad body 6410, and oriented toprovide a forward tilt to the neck frame 6000 a, as illustrated in FIG.6A.

FIGS. 60-6Q illustrate side views of three different embodiments of arear bracket 6430, a pair of which help to secure the shoulder frame6000 b to the upper-back frame 6000 c. Referring to FIG. 60, the rearbracket 6430 comprises a cup 6432 with a hemispherical interior mountedto the back end 6414 of the body of the shoulder pad. The cup 6432comprises a first opening 6434 opening towards the front. A rear opening6436 is provided opposite the front opening 6434. Mounted in the cup6432 is a ball 6440 sized and dimensioned to rotate and pivot therein. Afront arm 6442 extends backward from the ball 6440 through the rearopening 6436 of the cup. In the illustrated embodiment, a rear arm 6444telescopically extends from the front arm 6442. The front 6442 and rear6444 arms are relatively lockable, thereby providing an adjustableoverall length. A sleeve 6446 is mounted to the end of the rear arm 6444using a ball and socket joint 6448. The sleeve is sized and dimensionedto slidably receive an upper rod 6500 described below. Also illustratedin FIG. 6O is an optional push button locking mechanism 6449 thatengages corresponding openings 6502 formed on the upper rod.

FIG. 6P illustrates another embodiment of a rear bracket 6430′ which issimilar to the embodiment illustrated in FIG. 60. The illustratedembodiment comprises only a single arm 6442′ extending between the ball6440′ and the sleeve 6446′. In the illustrated embodiment, the arm 6442′extends through the ball 6440′, which comprises a locking mechanism ofany type known in the art, for example, a push button lock.

FIG. 6Q illustrates another embodiment of a rear bracket 6430″. In thisembodiment, a bracket 6432″ is mounted towards the rear 6414 of theshoulder pad. A pin 6438″ extends laterally from the bracket 6432″. Anarm 6442″ is equipped with a plurality of hooks 6443″, which are sizedand dimensioned to engage the pin 6438″. Applying tension to thestructure locks the selected hook 6443″ to the pin 6438″.

As text viewed in FIG. 6B, the upper-back frame 6000 c is operativelyconnected with the shoulder frame 6000 b through the rear bracket 6430and the shoulder straps 6450. The upper-back frame 6000 c comprises anupper rod 6500 slidably mounted to the rear sleeves 6446 brackets. Atelescoping vertical rod 6510 is mounted to about the center of theupper rod, for example, using a clip, and extends downwards therefrom. Alower rod 6520 is mounted to the vertical rod 6510 below the upper rod6500 for example, using clip. The upper 6500 and lower rods 6520 aresubstantially perpendicular to the vertical rod 6510. Mounted to theupper 6500 and lower 6520 rods, and flanking the vertical rod 6520, is apair of back plates 6530. Each back plate 6530 comprises a body 6532,which comprises a relatively rigid, strong, and lightweight material, anindependently inflatable upper-back chamber 6534. A mount point 6512,for example, an eyelet, is provided at bottom of the vertical rod 6510to which the shoulder straps 6450 are secured. In the illustratedembodiment, a hip belt 6540 is also mounted to the mount point 6512. Asbest viewed in FIG. 6C, the hip belt 6540 comprises an adjustable claspor buckle 6542.

FIG. 6D schematically illustrates a top view illustrating a user's headand the positions of the right 6010 a and left 6010 b lateral slats, therear slat 6020, and the front slat 6030. Left and right lateral slatsleeves 6300 are indicated by open circles. FIG. 7D illustrates theswiveling and alignment mechanism of the neck frame 6000 a which permitsrotational and translational positioning of the user's head. Because thelateral slat sleeves 6300 are positioned on the shoulder pads 6400 (notillustrated in this figure), the distance w₁ is constant. Accordingly,and as will become apparent, in some embodiments, no locking mechanismis needed to control the rotational degree of freedom of the lateralslat sleeves 6300. Illustrated in solid is a user's head and neck frame6000 a with the user facing forward.

Illustrated in phantom is a user's head and neck frame 6000 a after arotation to the right. As shown in the solid lines, the distance betweenthe left lateral slat sleeve 6300 a and the front slat 6030 is indicatedby d₁ when the user's head is facing straight ahead. On rotating thehead to the right, the distance between the left lateral slat sleeve6300 a and the front slat 6030 changes to d₂ as the left lateral slat6010 b slides forward in the left lateral slat sleeve 6300 b.Concomitantly, the right lateral slat 6010 a slides backward in theright lateral slat sleeve 6300 a to the position indicated because therear slat sleeves and the front slat sleeves permit sliding of the rearslat 6020 and front slat 6030, respectively, but do not permit rotation.Accordingly, the neck frame 6000 a is constrained to remainsubstantially rectangular. Consequently, on rotating the user's head tothe right, as indicated in FIG. 6D, the original width w₁ between thetwo rear slat sleeves or the two front slat sleeves changes to the widthw₂. As discussed above, the rear slat sleeves and front slat sleeves arelockable. Accordingly, when the positions of the rear slat 6020 andfront slat 6030 are locked relative to the lateral slats 6010, theresulting rectangle is also locked. If at least one of the lateral slats6010 were not lockable in a lateral slat sleeve 6300, the rectanglecould slide forward and/or backward in the lateral slat sleeves 6300.Providing a locking mechanism for the sliding motion on either the right6300 a or left 6300 b lateral slat sleeves, however, is sufficient toprevent the neck frame 6000 a from moving. Accordingly, in someembodiments, a locking mechanism for the lateral slat 6010 is providedon only one of the right 6300 a or left 6300 b lateral slat sleeves. Inother embodiments, locking mechanisms are provided on both.

Those skilled in the art will understand that different arrangements forthe neck frame 6000 a are used in other embodiments, for example, with adifferent geometry, and/or with more or fewer slats. In someembodiments, the slats form a different shape, for example, a pentagon,hexagon, or another polygon. In some embodiments, at least one of theslats is not generally straight, for example, curved, or a horseshoeshape.

The neck frame 6000 a also provides translational alignment of the headand neck. Front-back alignment is accomplished by sliding the lateralslats 6010 forward or backward in the lateral slat sleeves 6300, andlocking at least one of the lateral slat sleeves. Side-to-side alignmentis provided by sliding the back 6020 and front 6030 slats in concert inthe back 6100 and front 6200 slat sleeves, and locking the back 6100 andfront slat sleeves 6200. FIGS. 7A and 7B illustrate side and frontviews, respectively, of another embodiment of a neck-and-upper-backframe 7000. In the illustrated embodiment, the neck frame 7000 a swivelson the lateral slat sleeves 7300 and has an adjustable lower cervicaltilt using a tilting mechanism described below.

FIG. 7C illustrates a front view of a lateral slat sleeve 7300. The body7310 and locking mechanism 7302 are substantially similar to theembodiment of the lateral slat sleeve 6300 described above. The tiltinglever 7350 is also similar, comprising an enlarged head 7352, shank7356, and base 7354. The base 7354 is modified compared with the base inthe embodiment 6300, however. In the illustrated embodiment, the base7354 is sized and dimensioned to be slidably received in a channel 7416formed in the body 7410 of each shoulder pad 7400. In the illustratedembodiment, a push button locking mechanism 7358 is also provided topermit user control of the tilt. The push button 7358 engages suitableholes or openings 7418 (FIG. 7B) provided on the body 7410 of theshoulder pad. A line of openings 7418 extends substantially in parallelwith the channel 7416. The channel 7416 extends from the front end 7412of the frame towards the back end 7414.

In use, the tilting lever 7350 (and lateral slat sleeve 7300) isunlocked by depressing the push button lock 7350. The forward-backwardposition of the lateral slat sleeve 7300 is adjusted by sliding the base7354 in the channel 7416, and the position locked when the push buttonlock 7350 engages the desired opening 7418.

FIGS. 8A and 8B illustrate in side view and back view an embodiment of aneck-and-upper-back frame 8000, which is similar to the embodiment 7000illustrated and described above, and further comprises adjustableoccipital cups and an adjustable chin cup.

In the illustrated embodiment, the height of each occipital cups 8600 isuser adjustable. Each occipital cup 8600 is also equipped withself-adjusting swivel and tilt. Similarly, the height of the chin cup8700 is user adjustable, and equipped with self-adjusting forward andbackward tilt. The user controlled and self-adjustment mechanisms are ofany suitable type known in the art.

FIGS. 8C and 8D are side and back views, respectively, of an embodimentof an adjustable occipital cup 8600. The occipital cup 8600 comprises abody 8602 in which an inflatable rear chamber 8604 is disposed. As bestseen in FIG. 8D, the body 8602 is pivotably mounted to a post 8610 usinga pair of pivot arms 8612, thereby providing sagittal tilt as indicatedby the arrow in FIG. 8C. The post is, in turn, mounted to a sleeve 8620comprising an opening 8622 through which the post 8610 is slidable.Height adjustment is provided in the illustrated embodiment using a pushbutton 8612 mounted to the post 8610, which engages correspondingopenings on the sleeve 8620. The sleeve 8620 also comprise a pair oftabs 8624, which are sized and dimensioned to engage a radial grooveformed in a rear slat as described below. FIG. 8E illustrates top viewswith arrows illustrating the rotational adjustment of the sleeve 8620.

FIGS. 8F and 8G are a top view and a bottom view of an embodiment of arear slat 8020 used in conjunction with the occipital cups 8600. Therear slat 8020 comprises a first or right end 8022 and a second or leftend 8024. A series of holes or openings 8026 extends toward the centerfrom either end of the rear slat 8020. The openings 8026 are used incombination with the rear slat sleeve 8000 for locking the rear slat8020. Near the center of the rear slat 8020 is provided a pair ofopenings 8028 sized and dimensioned for mounting the sleeves 8620occipital cups. FIG. 8H illustrates a close up top view of an opening8028. FIG. 8I is a cross-section of the opening 8028 taken throughsection I-I in FIG. 8H. As illustrated in FIG. 8I, the opening 8028comprises a hole 8029 extending through the rear slat 8020, and a radialgroove 8027. As shown in FIG. 8H, a pair of notches 8027 a are provided,which are sized and dimensioned provide access to the radial groove 8027by the tabs 8624 of the sleeve of the occipital cup 8600. Rotating thetabs 8624 in the radial groove 8027 captures them therein. Thisarrangement permits the tabs 8624 to rotate freely in the radial groove8027. In the illustrated embodiment, the hole 8029 comprises alongitudinal groove 8029 a, which provides clearance for the push button8612 on the post of the occipital cup 8600.

FIGS. 8J and 8K illustrates an embodiment of an adjustable chin cup 8700which comprises a body 8702 which is in the illustrated embodiment isgenerally L-shaped. Disposed within the L of the body 8702 is the frontair chamber 8710, which is similar to the air chamber 6710 describedabove. The body 8702 of the chin cup is mounted on a pair of pivot arms8722, which are in turn mounted to a post 8720, thereby providing aself-adjusting sagittal tilt as indicated by the arrows in FIG. 8J. Thepost 8720 is sized and dimensioned to be received in a sleeve mounted ona front slat 8030, as discussed below. Height adjustment is providedthrough a push button 8722 that cooperates with a corresponding openingin the sleeve, described below. Other embodiments use other adjustmentmeans are known in the art.

FIGS. 8K and 8L are top and front views respectively of an embodiment ofthe front slat 8030 used with the chin cup 8700. The front slatcomprises a first or right end 8032 and a second or left end 8034. Aplurality of openings or holes 8036 extend from either end towards thecenter, which are used in conjunction with the front slat sleeve 8200 tolock the front slat 8030 in position. A sleeve 8038, which is sized anddimensioned to receive the corresponding post 8720 on the chin cup, ismounted at about the center of the top of the front slat 8030. Anopening 8039 is provided at the front of the sleeve 8030 that engagesthe corresponding push button 8722 on the post of the adjustable chincup, which provides height adjustment.

Another embodiment of the neck-and-upper-back frame 9000 illustrated inFIGS. 9A and 9B in side view and front view, respectively. Theembodiment 9000 is similar to the embodiment 8000 described above, withthe addition of a middle cervical tilt feature described below. As bestseen in FIG. 9A, the lateral slat sleeve 9300 includes a middle tiltlocking mechanism, which permits the user to tilt the lateral slats 9010upwards and downwards.

Those skilled in the art will understand that other embodiments provideadjustability of the either of the occipital cups 8600 and/or chin cup8700 using different means, configurations, or structures know in theart, for example, ball joints, hinges, screws, racks-and-pinions, gears,resilient structural and/or support members, fluid-filled pistons,combinations thereof, and the like. Furthermore, those skilled in theart will understand that either of the occipital cups 8600 and/or chincup 8700 has a different shape and/or dimensions in other embodiments.

FIG. 9C illustrates a front view of a lateral slat sleeve 9300implementing a middle cervical tilt feature. The lateral slat sleeve9300 comprises a body 9310 at the lower portion of which is formed abushing 9316, which is substantially similar to the bushings describedabove in the embodiments of the lateral slat sleeves 6300 and 7300. Thearrangement of the tilting lever 6350 is similar to the tilting lever ofthe embodiment of the lateral slat sleeve 7300 described above.

The body 9310 comprises a pivot and locking plate 9360 extending from aside of the bushing 9316, such that the faces of the plate 9360 faceleft and right, as illustrated in FIG. 9A. A channel 9312 is pivotablymounted to the plate 9360 to provide a middle cervical tilt. The channel9312 is sized and dimensioned to slidably receive a lateral slat 9010therethrough. A lever and plunger locking mechanism 9302 is provided forlocking the sliding motion of the lateral slat 9010 in the channel 9312.The channel 9312 is equipped with a push button locking mechanism 9362that cooperates with a plurality of holes or openings 9364 formed on theplate to lock the up and down pivoting motion of the middle cervicaltilt. Those skilled in the art will understand that the openings 6364are disposed at a substantially constant radius from the middle-tiltpivot point.

Each of the neck-and-upper-back frames 6000, 7000, 8000, and/or 9000comprises one or more features that are independently applicable and/orcombinable in other embodiments. For example, the embodiment 6000includes a swiveling neck frame that permits rotational andtranslational alignment of the head. The swiveling neck frame feature ispresent on each of the disclosed embodiments. The embodiment 7000includes a lower cervical tilt feature, implemented using adjustabletilt levers that are longitudinally adjustable on the shoulder pads. Theembodiment 8000 includes the lower cervical tilt feature, as well asadjustable occipital and chin cups. The embodiment 9000 adds a middlecervical tilt feature to the embodiment 8000 implemented in the lateralslat sleeves. Each of these embodiments also includes other features.Those skilled in the art will understand that some embodiments implementthe features of the neck-and-upper-back frames 6000, 7000, 8000, and/or9000, in different combinations.

Each of the disclosed neck-and-upper-back frames comprises seven airchambers. The neck frame comprises a left and a right rear chamber, eachengaging the corresponding left and right occipital regions of the head(also referred to herein as “occipital processes,” “occipitalprotuberances,” or “occipital regions”), and a front chamber disposedunder the user's chin. The shoulder frame comprises a left and a rightshoulder chamber. The upper-back frame comprises a left and a rightupper-back chamber. Each of the air chambers comprises a suitableflexible and gas tight material known in the art, for example, apolymer, natural rubber, synthetic rubber, combinations thereof, and thelike. In some embodiments, the material is a composite, for example,fibers and/or fabric impregnated with and/or covered with a flexible andgas tight material. In some embodiments, the material is elastomeric.Suitable materials for air chambers are discussed in greater detailabove. Each air chamber includes one or more inflation ports throughwhich the air chamber is inflated and/or deflated. Fluidly connecting aninflation port with a source of pressurized gas causes an air chamber toinflate, and fluidly opening an inflation port to ambient or sub-ambientpressure causes the air chamber to deflate.

Those skilled in the art will understand that in some embodiments,pressurized gas is supplied to one or more of the inflation ports of theair chambers through tubing fluidly connected to one or more manifoldsof any suitable type known in the art. The tubing is of any suitabletype known in the art, for example, rubber, vinyl, silicone, plastic,metal, combinations thereof, and the like. In some embodiments, thedeflation of one or more of the air chambers is also implemented usingone or more manifolds. In some preferred embodiments, the inflation anddeflation all of the air chambers are controlled using a manifold. Themanifold is user controlled, automated, or a combination thereof. Insome preferred embodiments, the manifold is automated, for example,controlled by a computer, microprocessor, embedded processor, or thelike. In some embodiments, a user generated pressurized gas, forexample, a hand bulb, hand pump, or foot pump, is used to inflate atleast one of the air chambers. In some embodiments, a non-user generatedpressurized gas is used to inflate at least one of the air chambers, forexample, a mechanical air pump, compressor, or compressed gas cylinder.In some preferred embodiments, the manifold is supplied using a non-usergenerated pressurized gas.

In some embodiments, the manifold independently controls the inflationstate of each of the air chambers. In some embodiments, the inflationstate of some of the air chambers is controlled together at least someof the time.

FIG. 10 illustrates an embodiment of a user controlled manifold 1000 andsource of pressurized gas 1010 in fluid connection therewith suitablefor use with some embodiments of the disclosed neck-and-upper-backframes and methods disclosed herein. In the illustrated embodiment, thesource of pressurized gas 1010 is a hand bulb. The manifold comprises aplurality of manually activated valves of any suitable type, labeled 1-8in FIG. 10, each of which control the inflation of one or more of theair chambers. The gas exits the manifold 1000 through a plurality ofoutlet ports 1020, 1030, 1040, 1050, 1060, and 1070. The correspondencebetween the valves, outlet ports, and air chambers for the illustratedembodiment is provided in TABLE I. In the illustrated embodiment, theshoulder air chambers are inflated together rather than separately.Those skilled in the art will understand that other arrangements for themanifold, and the control scheme are used in other embodiments. TABLE IValve Outlet Port Air Chamber 1 1020 Left Rear 2 1030 Right Rear 3 1020and 1030 Left and Right Rear 4 1040 Front 5 1050 Left Upper Back 6 1060Right Upper Back 7 1050 and 1060 Left and Right Upper Back 8 1070 Leftand Right Shoulder

Each of the disclosed neck-and-upper-back frames is also useful forimplementing embodiments of the method 400 for spiral traction describedabove. The following description of the method references certain of thedisclosed embodiments of the neck-and-upper-back frame, but thoseskilled in the art will understand that the methods are also applicableto other embodiments.

In step 410, the neck-and-upper-back frame 6000 is positioned andsecured to the patient. In some embodiments, the shoulder 6000 b andupper-back 6000 c frames are first positioned and secured to the patientto provide the state illustrated in FIG. 6C. The shoulder 6000 a andupper-back 6000 c frames are first assembled and put on and worn by theuser in much the same way that a jacket is.

The shoulder pads 6400 are positioned on the patient's shoulders.Referring to FIG. 6B, the distance between the sleeves 6446 of the rearbrackets is adjusted on the upper rod 6500 of the upper-back frame 6000c according the patient's shoulder width. The lengths of the rearbrackets 6430 are adjusted to match the tilt of the upper-back frame6000 c to the tilt of the lower thoracic spine. There should be a smallspace between the upper-back chambers 6534 and the spine. The length ofthe vertical rod 6510 is adjusted to the patient's waist. The cheststrap 6460 and hip belt 6540 are adjusted and secured. In embodimentcomprising adjustable tilting levers (7000, 8000, and 9000), the tiltinglevers are adjusted and locked in their rearmost positions.

The neck frame 6000 a is then assembled. The lateral slats 6010 are slidthrough the lateral slat sleeves 6300, and the rear 6020 and front 6030slats mounted on the lateral slats 6010 using the rear slat sleeves 6100and front slat sleeves 6300, respectively. The occipital cups 6600 aremounted to the rear slat 6020. The chin cup 6700 is mounted to the frontslat 6030.

The neck frame 6000 a is mounted to the shoulder frame 6000 b byengaging the bushings 6316 of the lateral slat sleeves to the heads 6352of the tilting levers, and the retaining pins 6318 inserted. Thepositions of the occipital cups 6600 are adjusted such that the rearchambers engage the patient's occipital regions of the head, forexample, by adjusting the forward positions of the lateral slats 6010 inthe lateral slat sleeves 6300, and/or using the lower cervical tilt inembodiments with this feature, and/or adjusting the heights of theoccipital cups in embodiments with this feature. TMJ spacers 300 (FIG.6A) are inserted and positioned in the patient's mouth. The use andbenefits of the TMJ spacers 300 are discussed in above. The position ofthe chin cup 6700 is adjusted such that the front chamber contacts thechin and extends about halfway to the angle of the mandible, forexample, by adjusting the height of the chin cup in embodiments withthis feature. In some embodiments, the front chamber is inflated tocontact the user's chin, for example, where the chin cup is notadjustable.

In step 420, the spine is aligned. Each of the disclosed embodiments ofthe neck-and-upper-back frame permit the alignment of the cervicalvertebrae, and at least some of the thoracic vertebrae. The discloseddevices permit orientation of the spine in any direction along thesagittal, coronal, and transverse directions prior to the application ofaxial traction to the spine. The following describes a preferred andnon-exclusive embodiment for aligning the spine.

The neck frame permits rotational and translational positioning andalignment of the patient's head, as discussed above and illustrated inFIG. 6D. In this step, the pre-traction rotation of the neck frame isadjusted as discussed above.

The lower pre-traction tilt is then adjusted for extension or flexion asdesired. In embodiments with a lower cervical tilt feature, thepositions of the tilting levers 7350 (FIG. 7C) are adjusted on theshoulder pads 7400 using the push button 7358 and openings 7418 (FIG.7B) as discussed above. In embodiments with middle cervical tilt, thetilt of the channels 9312 (FIG. 9C) is adjusted using the push button9362 and corresponding opening 9364 of the lateral slat sleeve 9300, asdiscussed above. In some embodiments, the lower pre-traction tilt isadjusted by inflating the rear and/or front chambers. The sidepre-traction tilt is adjusted using the rear chambers.

In step 430, traction is applied using the air chambers of the neckframe 6000 a (front, right rear, and left rear). In some embodiments ofthis step, the patient is in different positions, for example, standing,sitting, reclining, lying down, etc.

In some embodiments, the shoulder chambers 6420 are inflated, whichstretches the neck downward, thereby stretching the trapezius muscles.In some embodiments, the upper-back chambers 6534 permit user controlledflexion, extension, rotation, and lateral flexion of the upper back. Forexample, in some embodiments, the left or right upper-back chamber 6534is inflated to rotate the upper back to correct rotational scoliosis.Inflating one the right or left upper-back chambers 6534 produces bothrotation and lateral flexion in the thoracic spine due to the coronalorientation of the facet joints in this area of the spine. These stepsare optional when the traction is repeated as discussed below.

Some embodiments comprise steps of axial distraction of the necksimultaneous with one of extension, flexion, or lateral flexion. Inpreferred embodiments, one of the spiral traction sequences describedabove (circular or figure-eight) is then applied using the air chambersof the neck frame 6000 a.

In step 440, the neck frame air chambers are then deflated.

In step 450, steps 430 and 440 are optionally repeated one or moretimes. Repeated step(s) 430 uses the same and/or a different sequence.In some preferred embodiments, the spiral traction sequence is thefigure-eight sequence, which is repeated once or twice.

It is believed that in selectively stretching of the neck in any of fourseparate directions, embodiments of the disclosed devices, systems, andmethods provide a combination of at least some of the followingbenefits: relaxing muscle spasms; releasing muscle contractures;releasing scar-tissue adhesions; improving circulation of blood, lymph,and cerebral-spinal fluid; draining edema surrounding muscles andjoints; decompressing spinal-joints; promote healing of spinal-jointcartilage; comfortably and effectively increasing intervertebraldisc-height; promoting healing of intervertebral disc tears; restoringalignment of cervical and/or upper-thoracic spinal-joints; reducingthoracic kyphosis and/or rotational scoliosis; decompressing spinalnerve-roots and/or brachial nerves; and/or improving TMJ function.Without being bound by any theory, it is believed that combinations ofthe following mechanisms provide these benefits.

Releasing Tight Muscles:

Lengthen Contracted Muscle Fibers. Muscle fibers lengthen as the neck isstretched in four separate directions from any position.

Release Reflex Muscle Spasms: Stretching a muscle triggers the“stretch-reflex,” which tends to contract that muscle; however, theantagonistic muscle group, which remains stationary, relaxes byreciprocal reflex innervation. Hence, muscle spasms relax by stretchingone side of the neck while the other side is stationary. The necktilting provided herein effectively stretches at least the followingmuscles and muscle groups:

Muscles Stretched with Side-Tilt. Sterno-cleido-mastoid, scalenes (ant.med. post.), splenius capitis, levator scapulae, multifidus,suboccipital muscles, obliquus capitis superior, obliquus capitisinferior.

Muscles Stretched with Forward-Tilt: Suprahyoid muscles, digastric(post. belly), stylohyoid, trapezius (vertical fibers), semispinaliscapitis, suboccipital muscles, rectus capitis posterior major, rectuscapitis posterior minor.

Muscles Stretched with Back-Tilt: Platysma, suprahyoid muscles,digastric (ant. belly), mylohyoid, infrahyoid muscles, omohyoid,stemohyoid, thyrohyoid.

Prevent Muscle Spasms During Traction: Spasm of the posterior cervicalmusculature and of the masseter muscle secondary to TMJ irritation isavoided in some embodiments during traction by the disclosed mechanismsthat decompress the TMJ using the disclosed TMJ spacers.

Promoting Healing and Flexibility of Connective Tissue

Releasing Scar Tissue Adhesions: Adhesions that form with surgery,injury, or repetitive motion in different planes of the connectivetissue fascia are released by stretching the neck from differentpositions and in four separate directions.

Reducing Bulging Spinal Discs: Bulges in torn spinal discs are reducedas scar tissue adhesions that form in different planes around the spinaldiscs are released by stretching the neck from different positions andin four separate directions.

Decompress Joint Cartilage: Cartilage on the surface of spinal joints isdecompressed as adhesions formed in different planes on the jointcapsule are released by stretching the neck from different positions andin four separate directions.

Promoting Circulation of Blood, Lymph, and CSF and Reducing Local TissueEdema

Improve Flow of Blood and Lymph: Blood flow is increased in the smallcapillaries and lymph flow is increased into the lymphatic vessels astight muscles and scar tissue that obstructs flow is released.

Drain Local Tissue Edema: Inflammatory and metabolic-waste fluidstrapped around spinal joints, nerves, and myofascial “Trigger Points”drain more easily as tight muscles and scar tissue obstructing flow isreleased.

Improve Circulation of Cerebral Spinal Fluid (CSF): Flow of cerebralspinal fluid in the brain and spinal cord is promoted as muscles in thesuboccipital area of the neck relax and stagnant fluid drains.

Promoting Healing of Nerve Tissue

Releasing Nerve Root Entrapment: Mechanical entrapment of nerve roots isreduced as muscles and scar tissue are released.

Releasing Peripheral Entrapment of Brachial Nerves: Mechanicalentrapment of peripheral nerves in the neck, chest, and wrist is reducedas the “Linked-Chain” of muscles that extends from the neck to theshoulder, chest, elbow, wrist, and fingers relax in succession.

Promoting Correct Spinal Alignment

Spinal joint alignment and range of motion improves as muscle tone isbalanced, adhesions are reduced, blood flow is promoted, inflammation isreduced, and spinal joint cartilage, discs, and nerves heal.

It is believed that at least some of these and/or other benefits areuseful in treating a variety of conditions. The following is anon-exclusive list of conditions treatable using the disclosed devices,systems, and methods.

Whiplash, Spinal Disc Injury, and Osteoarthritis (degenerative jointdisease or DJD): Lengthening contracted muscles, releasing soft tissueadhesions, improving blood flow, and reducing inflammation promoteshealing of spinal discs and spinal-joint cartilage.

Headaches and Fibromyalgia: Releasing muscle spasms and soft tissueadhesions helps to improve blood flow, drain metabolic waste-fluids, anddecompress nerve endings for pain relief in tension-headaches andchronic myofascial “Trigger-Point” Syndromes.

Thoracic-Outlet and “Multiple-Crush” Carpal-Tunnel: These benefits aregenerally observed in the disclosed neck-and-shoulder-fame systems.Releasing the scalene, rhomboid, and pectoralis minor muscles helps torelease nerve compression of the brachial plexus of nerves and of thesubclavian artery. The brachial plexus of nerves can be compressed inthe neck as it passes between the anterior and middle scalene muscles.Stretching the scalene muscles releases compression of the brachialplexus in the neck. The brachial plexus of nerves can be compressed inthe chest as it passes underneath the pectoralis minor muscle.Stretching the pectoralis minor muscle by expanding the chest, andlowering the scapula (shoulder-blade) by relaxing posterior neck muscles(e.g., trapezium, rhomboids), releases compression of the brachialplexus in the chest. The brachial plexus of nerves can be compressed inthe wrist as the median nerve passes through the carpal tunnel. Relaxingposterior neck muscles lowers the scapula and relaxes the biceps brachiimuscle, which originates from the front of the scapula and inserts intothe fascia of the wrist flexor muscles at the elbow; as a result, thewrist flexor muscles relax, helping to release compression of thebrachial plexus in the wrist.

Thoracic Kyphosis and Rotational Scoliosis: These benefits are generallyobserved in the disclosed neck-and-shoulder-fame systems. Extending androtating the upper-thoracic spine helps to reduce kyphosis andscoliosis.

TEMPORO-MANDIBULAR JOINT SYNDROME (TMJ): Stretching and relaxing thesuprahyoid and infrahyoid muscles helps to reduce pain and crepitus(clicking) in the TMJ. The suprahyoid muscles attach to the temporalbone or to the jaw (mandible), and control the TMJ directly. Theinfrahyoid muscles control the TMJ indirectly through the suprahyoidmuscles and their common attachment at the floating hyoid bone in thefront of the neck. The stylohyoid and the digastric (posterior belly)suprahyoid muscles attach to the temporal bone. They are stretched andrelaxed with forward tilt of the neck. The mylohyoid and the digastric(anterior belly) suprahyoid muscles attach to the mandible (jaw). Theyare stretched and relaxed with back tilt of the neck. The omohyoid,thyrohyoid, and stemohyoid infrahyoid muscles affect the TMJ indirectlythru the suprahyoid muscles with which they share the floating hyoidbone as a common point of insertion. They are stretched and relaxed withback tilt of the neck.

Central Nervous (CNS) System Conditions. The pumping action created bystretching the upper-cervical and suboccipital-areas in any directionimproves the flow of blood and CSF to the brain, and the flow ofwaste-fluids away from the brain, thereby decompressing and revitalizingthe CNS nerve tissue. Case studies published by Dr Erin Elster haveshown that improving upper-cervical alignment following a neck injuryhelps to improve neurologic conditions that are sometimes associatedwith neck trauma such as multiple sclerosis, Parkinson's, trigeminalneuralgia, torticollis, tremors, bipolar disorder, attention deficitdisorder, seizures, Alzheimer's and vertigo (Elster, J. VertebralSubluxation Res. 2001, 4(2)22-29, the disclosure of which isincorporated by reference.)

The embodiments illustrated and described above are provided as examplesof certain preferred embodiments. Various changes, modifications,substitutions can be made to the embodiments presented herein by thoseskilled in the art without departure from the spirit and scope of thisdisclosure, the scope of which is limited only by the claims appendedhereto.

Those skilled in the art will understand that changes in the devices,systems, and/or methods described above are possible, for example,adding and/or removing components and/or steps, and/or changing theirorders. While the above detailed description has shown, described, andpointed out novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the device or process illustrated may be made bythose skilled in the art without departing from the spirit of thisdisclosure. As will be recognized, some embodiments do not provide allof the features and benefits set forth herein, and some features may beused or practiced separately from others.

1. A neck-and-upper-back frame system for cervical traction on a usercomprising: a top and a bottom; a front and a back; a left side and aright side; a neck frame comprising: a plurality of lockably slidableslats; an inflatable front chamber sized and dimensioned to engage auser's chin, and coupled to at least one of one of the slats; aninflatable right rear chamber sized and dimensioned to engage the rightoccipital region the user's head, and coupled to at least one of theslats; and an inflatable left rear chamber sized and dimensioned toengage the left occipital region the user's head, and coupled to atleast one of the slats, wherein the plurality of slats is slidablyadjustable for simultaneous engagement of the front chamber to theuser's chin, the right rear chamber to the right occipital region of theuser's head, and the left rear chamber to the left occipital region ofthe user's head; and a shoulder frame comprising right and left shoulderpads sized and dimensioned for simultaneously engaging a user's rightand left shoulders, respectively, wherein each shoulder pad comprises afront end and a back end defining a longitudinal axis, and the neckframe is coupled to the shoulder frame, and the neck frame's positionwith respect to the shoulder frame is adjustable.
 2. Theneck-and-upper-back frame system of claim 1, wherein the neck frame isswivelably coupled to the shoulder frame.
 3. The neck-and-upper-backframe system of claim 1, wherein each shoulder pad comprises aninflatable shoulder chamber positioned to contact the user's shoulder.4. The neck-and-upper-back frame system of claim 1, further comprisingan upper-back frame operatively coupled to the back ends of the shoulderpads, wherein the upper-back frame comprises: an inflatable rightupper-back chamber sized and dimensioned to contact a user's right upperback; and an inflatable left upper-back chamber sized and dimensioned tocontact a user's left upper back, wherein the upper-back frame andshoulder frame together are securable to the user.
 5. Theneck-and-upper-back frame system of claim 1, wherein the sliding of atleast one of the slats is lockable using a slat sleeve comprising aplunger sized and dimensioned to engage an opening in theslat-to-be-locked.
 6. The neck-and-upper-back frame system of claim 1,wherein the plurality of slats comprises: a left lateral slat and aright lateral slat generally defining right and left sides of arectangle; and a rear slat and a front slat generally defining rear andfront sides of the rectangle; a right occipital cup comprising the rightrear chamber is coupled to the rear slat; a left occipital cupcomprising the left rear chamber is coupled to the rear slat; and a chincup comprising the front chamber is coupled to the front slat.
 7. Theneck-and-upper-back frame system of claim 6, further comprising: a rightslat sleeve coupled to the right shoulder pad; and a left slat sleevecoupled to the left shoulder pad, wherein the right lateral slat isslidably coupled in the right slat sleeve; the left lateral slat isslidably coupled in the left slat sleeve; and the sliding of the lateralslat in at least one of the left slat sleeve or the right slat sleeve islockable.
 8. The neck-and-upper-back frame system of claim 6, wherein aheight of at least one of the right occipital cup, the left occipitalcup, or the chin cup is user adjustable.
 9. The neck-and-upper-backframe system of claim 6, wherein a sagittal tilt of at least one of theright occipital cup, the left occipital cup, or the chin cup isadjustable.
 10. The neck-and-upper-back frame system of claim 1, whereinthe neck frame is lockably slidable forward and backward relative to theshoulder frame.
 11. The neck-and-upper-back frame system of claim 10,wherein the neck frame is coupled to a right tilting lever and a lefttilting lever, the right tilting lever is lockably slidable along thelongitudinal axis of the right shoulder pad, and the left tilting leveris lockably slidable along the longitudinal axis of the left shoulderpad.
 12. The neck-and-upper-back frame system of claim 1, wherein theneck frame is lockably pivotable relative to the shoulder frame around atransverse axis.
 13. The neck-and-upper-back frame system of claim 12,wherein the neck frame is coupled to a right slat sleeve and a left slatsleeve; the right slat sleeve is coupled to the right shoulder pad andis lockably pivotable around the transverse axis; and the left slatsleeve is coupled to the left shoulder pad and is lockably pivotablearound the transverse axis.
 14. The neck-and-upper-back frame system ofclaim 1, wherein the front chamber is generally boomerang-shaped,comprising a pair of arms converging at a point; the point is disposedat the front of the chin cup; and the front chamber is sized anddimensioned such that the point is positioned under a user's chin andthe arms extend about halfway to the angle of the mandible.
 15. Theneck-and-upper-back frame system of claim 1, further comprising a rightand a left temporomandibular joint spacer, each temporomandibular jointspacer comprising an inner wall, an upper wall, and an outer walldefining a channel, wherein the channel is sized and configured to coverat least partially the biting surface of at least one of the user'smolars or premolars.
 16. The neck-and-upper-back frame system of claim1, further comprising: a gas manifold in fluid connection with the frontchamber, the right rear chamber, and the left rear chamber; and a sourceof pressurized gas for influx of gas into the manifold.
 17. Aneck-and-upper-back frame system comprising: a means for simultaneousaxial distraction, and one of flexion, extension, or lateral flexion ofa user's spine; and a means for aligning a user's upper back, whereinthe distraction means is swivelably coupled to the alignment means. 18.A method for simultaneous axial distraction, and one of flexion,extension, or lateral flexion of a user's spine comprising: securing theneck-and-upper-back frame system of claim 1 to a patient; slidablyadjusting the plurality of slats to simultaneously engage the frontchamber to the user's chin, the right rear chamber to the rightoccipital region of the user's head, and the left rear chamber to theleft occipital region of the user's head; applying cervical traction bysequential inflation of the front chamber, right rear chamber, left rearchamber, or a combination thereof; deflating the front chamber, rightrear chamber, and left rear chamber; and optionally repeating applyingcervical traction.
 19. The method of claim 18, wherein the sequentialinflation comprises at least one of the following inflation sequences: asecond sequence comprising left rear, both rear, right rear, front; aphase-shifted variant thereof; or the reverse of the second sequence orphase-shifted variant.
 20. The method of claim 18, wherein thesequential inflation comprises at least one of the following inflationsequences: a second sequence comprising left rear, both rear, rightrear, front; a phase-shifted variant thereof; or the reverse of thesecond sequence or phase-shifted variant.
 21. The method of claim 18,further comprising at least one of extending, rotating, or laterallyflexing the thoracic spine prior to applying cervical traction byinflating at least one of a right upper back chamber or a left upperback chamber.
 22. The method of claim 18, further comprising stretchingthe user's trapezius muscles prior to applying cervical traction byinflating a right shoulder chamber and a left shoulder chamber.
 23. Themethod of claim 18, wherein the inflation of the front chamber, rightrear chamber, and left rear chamber is automated.